Infusion Apparatuses and Methods of Use

ABSTRACT

A method of providing a fluid communication path to an implanted device. The method includes positioning at least a portion of a slender pointed element within a catheter, penetrating a septum of an implanted device with the slender pointed element positioned within the catheter, positioning at least a portion of the catheter within the implanted device, removing the slender pointed element from the catheter, and retaining at least a portion of the catheter within the implanted device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.13/438,586, filed Apr. 3, 2012, which is a division of U.S. patentapplication Ser. No. 11/380,621, filed Apr. 27, 2006, now U.S. Pat. No.8,147,455, which claims the benefit of U.S. Patent Application No.60/675,309, filed Apr. 27, 2005, each of which is incorporated in itsentirety by reference into this application.

BACKGROUND

Access to a patient's vascular system may be established by a variety oftemporary or permanently implanted devices. For example, temporaryaccess to a patient's vascular system may be accomplished by the directpercutaneous introduction of a needle into the patient's blood vessel.While such a temporary and direct approach may be relatively simple andsuitable for applications that are limited in frequency or duration,such as intravenous feeding and/or intravenous drug delivery, thistemporary approach may not be suitable for procedures that arefrequently repeated or that require vascular access for relatively longtime periods of time, such as hemodialysis or other similarextracorporeal procedures.

Accordingly, a variety of implantable devices have been proposed toprovide a convenient method for repeatedly introducing fluids, such asmedicaments, into the vasculature of a patient. Typically, suchimplantable device comprise a housing that encloses an internal fluidchamber or cavity. An access aperture defined through the housing andsealed by a penetrable septum provides access to the internal fluidchamber, which is typically in fluid communication with an implantedcatheter attached to a patient's vasculature.

Quantities of fluid, such as medication, blood, or the like, may beintroduced into, or withdrawn from, a patient's vasculature usingconventional implantable device by: 1) penetrating the septum of theimplanted device using a percutaneously inserted needle; 2) positioningat least the tip of the needle within the internal fluid reservoir orcavity enclosed in the device housing; and 3) discharging fluids throughthe needle into the internal fluid cavity. The discharged fluids maythen be directed through the distal end of the implanted catheterconnected to the implanted device to an entry point into the venoussystem of the body of the patient. Blood may also be aspirated throughthe implanted device in a similar manner.

SUMMARY

In at least one embodiment, an infusion apparatus for providing accessto an implanted device, such as an access port or a pump (e.g., aso-called pain pump), may comprise an insertion assembly, a hubcomprising a sealable path configured to receive at least a portion ofthe insertion assembly, a flexible catheter attached to the hub andconfigured to receive at least a portion of the insertion assembly, andan extension tube attached to the hub. In certain embodiments, the hubmay comprise a plurality of wing structures and may be configured toprovide fluid communication between the flexible catheter and theextension tube. The hub may also comprise a manifold element structuredto provide fluid communication between the flexible catheter and theextension tube. In addition, the sealable path may comprise a septumconfigured to seal the sealable path upon removal of the insertionassembly from the flexible catheter. The extension tube may either bepermanently or removably attached to the hub.

According to at least one embodiment, the insertion assembly maycomprise a slender pointed element and both the sealable path and theflexible catheter may be configured to receive at least a portion of theslender pointed element. Similarly, the extension tube may be configuredto receive at least a portion of the slender pointed element. Theflexible catheter may also comprise at least one aperture definedproximate a distal end of the flexible catheter and the slender pointedelement may comprise at least one longitudinally extending indentationdefined along the slender pointed element. In at least one embodiment, across-sectional area defined between an exterior surface of the slenderpointed element and an interior surface of the flexible catheter mayapproximate the cross-sectional area of a hollow needle gauge. Inaddition, the flexible catheter may comprise at least one aperturedefined proximate a distal end of the flexible catheter and the slenderpointed element may be at least partially hollow and comprise at leastone aperture defined within the slender pointed element forcommunicating fluid with the at least one aperture defined in theflexible catheter.

In certain embodiments, at least a portion of the slender pointedelement may be retractable into a recess defined in the insertionassembly. In addition, the flexible catheter may have a length thatexceeds an anticipated insertion length such that, when the flexiblecatheter is fully inserted into a device implanted within a patient, abendable portion of the flexible catheter may extend from a skin surfaceof the patient. The infusion apparatus may also comprise a receivingenclosure positioned substantially parallel to a skin surface of apatient and configured to receive at least a portion of the hub.Further, the infusion apparatus may comprise a safety clip configuredto: 1) retain a pointed end of the slender pointed element within thesafety clip when the slender pointed element is removed from the hub;and 2) allow the pointed end of the slender pointed element to passthrough the safety clip when the slender pointed element is insertedinto the hub. The infusion apparatus may also comprise a reinforcingmember, which may be coiled, at least partially imbedded within theflexible catheter.

In at least one embodiment, an infusion device for use with an implanteddevice may comprise a slender pointed element comprising a pointed end,a flexible catheter comprising a sealable path configured to receive atleast a portion of the slender pointed element, and an extension tube influid communication with the flexible catheter. In certain embodiments,the sealable path may be structured to seal upon removal of the slenderpointed element from the flexible catheter.

In addition, an infusion apparatus for accessing an implanted device maycomprise an insertion assembly comprising a slender pointed element, ahub comprising a sealable path configured to receive at least a portionof the slender pointed element, a flexible catheter attached to the huband configured to receive at least a portion of the slender pointedelement, and an extension tube attached to the hub. In certainembodiments, the hub may comprise a manifold element structured toprovide fluid communication between the flexible catheter and theextension tube, and a septum configured to seal the sealable path uponremoval of the slender pointed element from the flexible catheter.

In at least one embodiment, a method of providing a fluid communicationpath to an implanted device may comprise positioning at least a portionof a slender pointed element within a flexible catheter, penetrating aseptum of an implanted device with the slender pointed elementpositioned within the flexible catheter, positioning at least a portionof the flexible catheter within the implanted device, removing theslender pointed element from the flexible catheter, and retaining atleast a portion of the flexible catheter within the implanted device.The method may also comprise providing a hub in fluid communication withthe flexible catheter, and removably attaching an extension tube to thehub to provide fluid communication between the flexible catheter and theextension tube. In addition, the method may comprise sealing a sealablepath defined in the hub upon removal of the slender pointed element fromthe flexible catheter.

In certain embodiments, this exemplary method may further comprisepositioning at least a portion of the slender pointed element within theextension tube. In addition, this method may further comprise retractingat least a portion of the slender pointed element into the flexiblecatheter. The method may also further comprise providing a safety clipproximate a pointed end of the slender pointed element, and retainingthe pointed end of the slender pointed element within the safety clipupon removal of the slender pointed element from the flexible catheter.

Features from any of the above-mentioned embodiments may be used incombination with one another in accordance with the general principlesdescribed herein. These and other embodiments, features and advantageswill be more fully understood upon reading the following detaileddescription in conjunction with the accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate a number of exemplary embodimentsand are a part of the specification. Together with the followingdescription, these drawings demonstrate and explain various principlesof the instant disclosure.

FIG. 1 is a schematic cross-sectional side view of an exemplary deviceimplanted within a patient;

FIG. 2 is an exploded perspective view of an exemplary infusion systemaccording to at least one embodiment;

FIG. 3A is a perspective view of an exemplary insertion assemblyaccording to at least one embodiment;

FIG. 3B is a cross-sectional side view of the exemplary insertionassembly illustrated in FIG. 3A;

FIG. 4A is a perspective view of an exemplary hub according to at leastone embodiment;

FIG. 4B is a cross-sectional side view of the exemplary hub illustratedin FIG. 4A;

FIG. 4C is a cross-sectional side view of an exemplary flexible catheterand extension tube attached to the exemplary hub illustrated in FIG. 4A;

FIG. 5 is a perspective view of an extension tube, clamp device, andtube connector according to at least one embodiment;

FIG. 6 is a perspective view of a safety clip according to at least oneembodiment;

FIG. 7 is a partial perspective view and partial cross-sectional sideview of a flexible catheter according to at least one embodiment;

FIG. 8A is an assembled perspective view of the exemplary infusionsystem illustrated in FIG. 1;

FIG. 8B is a partial cross-sectional side view of the exemplary infusionsystem illustrated in FIG. 8A;

FIG. 8C is a partial perspective view of a slender pointed elementaccording to at least one embodiment;

FIG. 8D is an end view of the exemplary slender pointed elementillustrated in FIG. 8C;

FIG. 8E is a cross-sectional side view of the exemplary slender pointedelement illustrated in FIG. 8C positioned within an exemplary flexiblecatheter;

FIG. 9A illustrates various exemplary geometrical attributes of alongitudinally extending indentation defined along a slender pointedelement according to at least one embodiment;

FIG. 9B is a schematic end view of a slender pointed element accordingto at least one embodiment;

FIG. 9C is a schematic end view of a slender pointed element accordingto an additional embodiment;

FIGS. 10A-10E are perspective views of various exemplary embodiments ofa flexible catheter;

FIG. 11A is a perspective view of an exemplary embodiment of a slenderpointed element;

FIG. 11B is a cross-sectional end view of the exemplary slender pointedelement illustrated in FIG. 11A, taken along the line 11B-11B;

FIG. 11C is a perspective view of an additional embodiment of a slenderpointed element;

FIG. 11D is a cross-sectional end view of the exemplary slender pointedelement illustrated in FIG. 11C, taken along the line 11D-11D;

FIG. 11E is a perspective view of an additional embodiment of a slenderpointed element;

FIG. 11F is a cross-sectional end view of the exemplary slender pointedelement illustrated in FIG. 11E, taken along the line 11F-11F;

FIG. 11G is a perspective view of an additional embodiment of a slenderpointed element;

FIG. 11H is a cross-sectional end view of the exemplary slender pointedelement illustrated in FIG. 11G, taken along the line 11H-11H;

FIG. 12A is a cross-sectional side view of a portion of a slenderpointed element and a flexible catheter according to at least oneembodiment;

FIG. 12B is a schematic perspective view of the exemplary slenderpointed element and flexible catheter illustrated in FIG. 12A;

FIG. 13 is a partial cross-sectional side view of an additionalembodiment of a flexible catheter;

FIG. 14A is a simplified cross-sectional side view of an additionalembodiment of a hub;

FIG. 14B is a simplified cross-sectional side view of an exemplaryinsertion assembly positioned within the exemplary hub illustrated inFIG. 14A;

FIG. 15 is a simplified cross-sectional side view of an additionalembodiment of an infusion system;

FIG. 16 is a simplified cross-sectional side view of an additionalembodiment of a hub;

FIG. 17A is a perspective view of an exemplary embodiment of a receivingenclosure for use with an infusion system;

FIG. 17B is a perspective view of an exemplary infusion systempositioned within the exemplary receiving enclosure illustrated in FIG.17A;

FIG. 18A is a perspective view of an additional embodiment of aninfusion system;

FIG. 18B is a cross-sectional side view of the exemplary infusion systemillustrated in FIG. 18A;

FIG. 19A is a perspective view of an additional embodiment of aninfusion system;

FIG. 19B is a cross-sectional side view of the exemplary infusion systemillustrated in FIG. 19A;

FIG. 19C is a cross-sectional side view of an additional embodiment ofan infusion system;

FIG. 20A is a perspective view of an additional embodiment of aninfusion system;

FIG. 20B is a cross-sectional side view of the exemplary infusion systemillustrated in FIG. 20A;

FIG. 21A is a perspective view of an additional embodiment of aninfusion system;

FIG. 21B is a perspective view of a portion of the exemplary infusionsystem illustrated in FIG. 21A;

FIG. 21C is a perspective view of a portion of the exemplary infusionsystem illustrated in FIG. 21A;

FIG. 21D is a perspective view of a portion of the exemplary infusionsystem illustrated in FIG. 21A;

FIG. 21E is a cross-sectional side view of the exemplary infusion systemillustrated in FIG. 21A;

FIG. 22A is a cross-sectional side view of an exemplary safety cliphousing in a first position;

FIG. 22B is a cross-sectional side view of an exemplary safety cliphousing in a second position;

FIG. 23A is a perspective view of an additional embodiment of a safetyclip in a first position;

FIG. 23B is a perspective view of an additional embodiment of a safetyclip in a second position;

FIGS. 24A-24D are perspective and cross-sectional side views of anadditional embodiment of a safety clip;

FIG. 25A is a cross-sectional side view of an exemplary safety cliphousing removably attached to a hub;

FIG. 25B is a cross-sectional side view of an exemplary safety cliphousing adhered to a hub;

FIGS. 26A-26C are perspective views of an infusion system according toan additional embodiment;

FIGS. 27A and 27B are perspective views of additional embodiments of aninfusion system;

FIG. 28A is a perspective view of an infusion system according to anadditional embodiment;

FIG. 28B is a cross-sectional side view of the exemplary infusion systemillustrated in FIG. 28A;

FIG. 29 is a cross-sectional side view of an exemplary slender pointedelement comprising a scored pointed end;

FIGS. 30A-30B are perspective views of an infusion system according toan additional embodiment;

FIGS. 31A-31B are perspective views of an infusion system according toan additional embodiment;

FIGS. 31C-31D are cross-sectional side views of the exemplary infusionsystem illustrated in FIGS. 31A-31B;

FIGS. 32A-32B are perspective views of an infusion system according toan additional embodiment;

FIGS. 32C-32D are cross-sectional side views of the exemplary infusionsystem illustrated in FIGS. 32A-32B;

FIGS. 33A-33C are perspective views of an insertion assembly accordingto an additional embodiment; and

FIGS. 34A-34C are perspective views of an exemplary hub for an infusionsystem according to an additional embodiment;

Throughout the drawings, identical reference characters and descriptionsindicate similar, but not necessarily identical, elements. While theexemplary embodiments described herein are susceptible to variousmodifications and alternative forms, specific embodiments have beenshown by way of example in the drawings and will be described in detailherein. However, one of skill in the art will understand that theexemplary embodiments described herein are not intended to be limited tothe particular forms disclosed. Rather, the instant disclosure coversall modifications, equivalents, and alternatives falling within thescope defined by the appended claims.

DETAILED DESCRIPTION

Generally speaking, one or more of the exemplary apparatuses, devices,and/or methods described and illustrated herein may be employed forpercutaneously accessing a device, such as an access port or pump (e.g.,a so-called pain pump), implanted within a patient, such as exemplaryaccess port 320 illustrated in FIG. 1. Access port 320 generallyrepresents any device capable of being implanted within a patient, suchas an access port, pump, or other device known to those of skill in theart. As illustrated in FIG. 1, exemplary access port 320 may comprise ahousing 322 and a septum 326 defining a chamber 324. A catheter 332 influid communication with the vasculature 316 of a patient may beattached to housing 322 to provide a fluid communication path betweenexemplary access port 320 and vasculature 316. In at least oneembodiment, access port 320 is implanted within the interior of apatient; namely, below skin surface 310 and within subcutaneous zone312. In certain embodiments, access port 320 may be implanted beneathskin surface 310 by a distance in the range from about 3 mm to about 20mm, and/or from about 5 mm to about 15 mm. Housing 322 of access port320 may then be secured to deep fascia tissue 314 by a plurality ofsutures 328. Catheter 332 may be surgically implanted, indwelling, orsecured within the patient in any other manner known to those of skillin the art.

FIG. 2 is an exploded perspective view of an exemplary infusion system10 for accessing an implanted device, such as exemplary access port 320illustrated in FIG. 1. As seen in FIG. 2, exemplary infusion system 10may comprise an insertion assembly 20, a safety clip 30, a hub 40, aflexible catheter 90, an extension tube 70, a clamp device 60, and atube connector 80. Generally, the various components of infusion system10 may comprise any number or combination of suitable materials known tothose of skill in the art, such as metals, plastics, or polymers. Forexample, the various components of infusion system 10 may comprisepolytetrafluoroethylene (PTFE), polypropylene, silicone, stainless steel(e.g., AISI 304 stainless steel), fluorinatedethylenepropylene (FEP),perfluoroalkoxy (PFA), ethylenetetrafluoroethylene (ETFE),polyetheretherketone (PEEK®), polyurethane (including thermoplasticpolyurethanes, such as ISOPLAST®, TECOFLEX®, TECOTHANE®, CARBOTHANE®,TECOPLAST®, or TECOPHILIC®-type polyurethanes), or any number ofcombinations thereof.

FIGS. 3A and 3B are perspective and cross-sectional side views,respectively, of an exemplary insertion assembly 20. As seen in thesefigures, exemplary insertion assembly 20 may comprise a slender pointedelement 22 attached to a base member 28. Slender pointed element 22generally represents any structure capable of penetrating the septum ofan implanted device, such as septum 326 of access port 320. For example,slender pointed element 22 may represent a trocar, a coring ornon-coring needle, a cannula, or any other suitable hollow or solidstructure. Slender pointed element 22 may be entirely solid, entirelyhollow, or may include a solid pointed end 25 and an at least partiallyhollow body, as discussed in greater detail below. In addition, slenderpointed element 22 may comprise any conventional needle, trocar, orcannula material, such as stainless steel (e.g., AISI 304 stainlesssteel), plastic, or the like.

As seen in FIGS. 3A and 3B, a recess 24 may be defined within basemember 28. In at least one embodiment, recess 24 is configured toreceive one or more structural elements, such as, for example, safetyclip 30. Base member 28 may also comprise a coupling structure 26, whichgenerally represents any structure (e.g., a protrusion) or recesscapable of coupling base member 28 to an additional element, such as hub40. In at least one embodiment, coupling structure 26 couples to acomplimentary coupling recess 44 defined in hub 40 (illustrated in FIGS.4A-4C). In certain embodiments, base member 28 may be injection moldedor otherwise formed about slender pointed element 22 so as to capture aportion of slender pointed element 22 within the base member 28, as bestseen in FIG. 3B.

FIGS. 4A and 4B are perspective and cross-sectional views, respectively,of an exemplary hub 40 according to at least one embodiment. As seen inthese figures, exemplary hub 40 may comprise a plurality of wingstructures 41A and 41B attached to a hub body 50. In at least oneembodiment, wing structures 41A and 41B are configured to affixexemplary hub 40 to the skin of a patient. For example, wing structures41A and 41B may be taped, adhesively affixed, or otherwise attached tothe surface of a patient's skin, such as skin surface 310 in FIG. 1.Generally speaking, wing structures 41A and 41B may be formed in anynumber of shapes and sizes, including those illustrated in FIGS.20A-20B, 22A-22B, 25A-25B, 26A-26C, 27A-27B, 30A-30B, 31A-31B, and33A-33D. As detailed above, exemplary hub 40 and wing structures 41A and41B may comprise any number or combination of suitable materials knownto those of skill in the art, including, for example, TECOFLEX® 85A-B20.

As illustrated in FIG. 4B, in certain embodiments a coupling recess 44may be defined within hub body 50 and structured to receive thecomplimentary coupling structure 26 provided on base member 28.Similarly, a recess 42 may be defined in hub body 50 and configured toreceive both a slender pointed element (such as slender pointed element22) and a safety clip (such as safety clip 30), as discussed in greaterdetail below. A retaining lip 43 may also be provided within recess 42for retaining a safety clip, such as safety clip 30, within recess 42.

In at least one embodiment, a penetrable septum 48 may be provided inrecess 42 and positioned above a manifold element 61 defined inexemplary hub body 50. A cap element 46 may also be positioned aboveseptum 48 and configured to retain septum 48 within recess 42. Asillustrated in FIG. 4B, manifold element 61 may define a plenum 49 incommunication with a plurality of openings (e.g., openings 51, 53, and59) sealed by at least one septum (e.g., septum 48). An aperture 47 mayalso be defined within cap element 46 generally opposite opening 51 ofplenum 49. In certain embodiments, septum 48 may comprise any suitablematerial capable of suitably sealing opening 51 of plenum 49; including,for example, medical-grade polymers (such as silicone) and monomers(such as Ethylene Propylene Diene Monomer (“EPDM”), or other suitablematerials.

In at least one embodiment, exemplary hub 40 may be structured toreceive at least a portion of insertion assembly 20. For example, hub 40may be configured to receive at least a portion of a slender pointedelement, such as slender pointed element 22, within a sealable pathdefined within hub 40. In at least one embodiment, such a sealable pathmay be defined by, for example, recess 42, aperture 47, septum 48,opening 51, and opening 53. In this example, slender pointed element 22may be inserted into aperture 47 in cap element 46 and passed throughseptum 48 and openings 51 and 53. In certain embodiments, penetrableseptum 48 may be configured to seal opening 51 of plenum 49 upon removalof slender pointed element 22 from hub 40. Accordingly, slender pointedelement 22 of insertion assembly 20 may be inserted through and removedfrom septum 48 without compromising the seal provided across opening 51.Further, the presence of cap element 46 may allow for so-called power orhigh-pressure injection to occur via manifold element 61, whereinpressures within manifold element 61 may reach about 400 psi or higher.

In certain embodiments, manifold element 61 may be configured to providefluid communication between opening 53 and opening 59. Moreparticularly, as illustrated in FIG. 4C, manifold element 61 maycomprise a port extension 55 configured to receive at least a portion ofan extension tube, such as extension tube 70, and a port extension 65configured to receive at least a portion of a flexible catheter, such asflexible catheter 90. In at least one embodiment, an inner surface area52 within port extension 55 of manifold element 61 may support theportion of extension tube 70 positioned within manifold element 61, suchthat relatively high pressures may be experienced without failure ofextension tube 70. Similarly, an inner surface area 62 within portextension 65 of manifold element 61 may support the portion of flexiblecatheter 90 positioned within manifold element 61, such that relativelyhigh pressures may be experienced without failure of flexible catheter90.

As illustrated in FIG. 4B, hub 40 may also comprise a channel defined bya surface 57 and extending from opening 54 to opening 59 of manifoldelement 61. Such a channel may be sized and configured to receive atleast a portion of an extension tube, such as extension tube 70, and maybe formed prior to positioning of an extension tube within manifoldelement 61 or, in another embodiment, fabricated by forming (e.g.,injection molding, curing, etc.) hub body 50 around extension tube 70.In an additional embodiment, hub body 50 of hub 40 may simply terminatesubstantially at opening 59 of manifold element 61.

In certain embodiments, flexible catheter 90 may be affixed to innersurface 62 of port extension 65. Similarly, extension tube 70 may beaffixed to surface 52 of port extension 55. In one example, extensiontube 70 and flexible catheter 90 may be chemically bonded to innersurfaces 52 and 62 of manifold element 61, respectively. In anotherexample, an adhesive may be used to affix extension tube 70 and flexiblecatheter 90 to inner surfaces 52 and 62 of manifold element 61,respectively. Optionally, hub body 50 may be injection molded, cured, orotherwise formed around manifold element 61 (and, optionally septum 48,cap element 46, or both) and at least a portion of extension tube 70, asshown in FIG. 4C. Hub body 50 may also be formed around at least aportion of flexible catheter 90 in a similar manner. In addition, asdiscussed in greater detail below in connection with FIGS. 26A-26C and27A-27B, extension tube 70 and/or flexible catheter 90 may be configuredto be removably attached to manifold element 61 and/or hub 40.

FIG. 5 is a perspective view of an extension tube 70, a clamp device 60,and a tube connector 80 according to at least one embodiment. Extensiontube 70 generally represents any form of medical tubing known to thoseof skill in the art. Similarly, clamp device 60 generally represents anyform of tubing clamp known to those of skill in the art; including, forexample, a slide clamp, a so-called pinch clamp, or the like. Inaddition, tube connector 80 generally represents any form of tubingconnection or mechanism known to those of skill in the art; including,for example, a so-called Luer-type fitting or connector.

FIG. 6 is a perspective view of a safety clip 30 according to at leastone embodiment. Safety clip 30 generally represents any self-actuatingdevice for capturing a pointed end of a slender pointed element, such aspointed end 25 of slender pointed element 22. In the exemplaryembodiment illustrated in FIG. 6, safety clip 30 may comprise aplurality of legs 32A and 32B having curved end regions 36A and 36B,respectively, and a hole 34 sized for receiving a slender pointedelement, such as slender pointed element 22. Safety clip 30 may also besized to fit within the retaining lips 43 provided in recess 42 of hub40.

In at least one embodiment, safety clip 30 is attached to slenderpointed element 22 by passing the pointed end 25 of slender pointedelement 22 through hole 34 of safety clip 30, past legs 32A and 32B, andpast curved end regions 36A and 36B. Once pointed end 25 of slenderpointed element 22 has passed curved end regions 36A and 36B, legs 32Aand 32B may clamp around slender pointed element 22 to removably affixthe safety clip to slender pointed element 22. As slender pointedelement 22, together with safety clip 30, is inserted into recess 42defined in hub body 50, slender pointed element 22 may continue throughsafety clip 30 and into the sealable path defined in hub body 50. Inaddition, legs 32A and 32B of safety clip 30 may be biased such that,upon removal of slender pointed element 22 from the sealable pathdefined in hub body 50, curved end regions 36A and 36B may close aroundthe pointed end 25 of slender pointed element 22 to retain this pointedend 25 within the body of safety clip 30. Such a safety clip 30 mayprevent inadvertent insertion of slender pointed element 22 into anotherperson, such as a medical practitioner utilizing infusion system 10.

FIG. 7 is a partial perspective view and partial cross-sectional sideview of a flexible catheter 90 according to at least one embodiment. Asseen in this figure, flexible catheter 90 may comprise an elongatedlumen 94 extending between a first opening 91 and a second opening 93.Flexible catheter 90 may also comprise, proximate to second opening 93,a tapered transition region 95. As shown in FIG. 7, tapered transitionregion 95 may comprise a first tapered sub-region 96 and a secondtapered sub-region 98. In certain embodiments, second tapered sub-region98 is tapered more sharply than first tapered sub-region 96. Optionally,tapered transition region 95 may comprise a single taper and at leastone arcuate surface. Exemplary flexible catheter 90 may also comprise atleast one aperture 92 defined within flexible catheter 90 proximatesecond opening 93. In at least one embodiment, aperture 92 is definedthrough the tubular body of flexible catheter 90 to provide a fluidcommunication path between first opening 91 and aperture 92 throughlumen 94. As detailed above, flexible catheter 90 may comprise anynumber or combination of suitable materials known to those of skill inthe art, including, for example, TECOTHANE® (e.g., TECOTHANE® TT1055 D).

FIGS. 8A and 8B are assembled perspective and cross-sectional views,respectively, of the exemplary infusion system 10 illustrated in FIG. 1.As seen in these figures, when insertion assembly 20 is coupled toexemplary hub 40 via coupling structure 26 and coupling recess 44, atleast a portion of slender pointed element 22 may extend through safetyclip 30, through aperture 47 of cap element 46, and into flexiblecatheter 90. In at least one embodiment, the length of slender pointedelement 22 is chosen such that, when insertion assembly 20 is coupled tothe hub body 50 of exemplary hub 40, the pointed end 25 of slenderpointed element 22 extends beyond the second opening 93 of flexiblecatheter 90. Accordingly, when so assembled, slender pointed element 22and flexible catheter 90 provide, in combination, a rigid, pointedstructure capable of penetrating the septum of an implanted device, suchas septum 326 of the exemplary access port 320 illustrated in FIG. 1.

FIGS. 8C and 8D are perspective and end views, respectively, of aslender pointed element 22 according to at least one embodiment. As seenin these figures, slender pointed element 22 may be structured to enablefluid communication within flexible catheter 90. More particularly,slender pointed element 22 may be sized to allow for clearance betweenan exterior surface of slender pointed element 22 and an interiorsurface (i.e., lumen 94) of flexible catheter 90. For example, incertain embodiments slender pointed element 22 may comprise at least onelongitudinally extending indentation 27 defined along at least a portionof the length of slender pointed element 22. In particular, as shown inFIGS. 8C and 8D, slender pointed element 22 may comprise a plurality oflongitudinally extending indentations 27 defined along a longitudinalaxis 11 of slender pointed element 22. In addition, as seen in the endview of FIG. 8D, longitudinally extending indentations 27 may be definedalong the generally circular slender pointed element 22 so as to form asubstantially triangular cross section.

FIG. 8E is a cross-sectional side view of a slender pointed element 22positioned within an exemplary flexible catheter 90. As shown in thisfigure, slender pointed element 22 may be configured such that itspointed end 25 extends from second opening 93 of flexible catheter 90.In addition, as illustrated in FIG. 8E, slender pointed element 22 andflexible catheter 90 may be sized such that, when slender pointedelement 22 is fully inserted within flexible catheter 90, the exteriorsurface of slender pointed element 22 snugly fits within and contactsthe interior surface of flexible catheter within region 101. In certainembodiments, longitudinally extending indentations 27 may be sized andpositioned to provide a fluid communication path between apertures 92and first opening 91 of flexible catheter 90. In other words,longitudinally extending indentations 27 may provide a fluidcommunication path within an annulus 103 defined by the exterior surfaceof slender pointed element 22 and the interior surface (i.e., lumen 94)of flexible catheter 90.

FIG. 9A illustrates various exemplary geometrical attributes of alongitudinally extending indentation defined along a slender pointedelement according to at least one embodiment. As seen in this figure,the cross-sectional area defined between an exterior surface of slenderpointed element 22 and an interior surface of flexible catheter 90(hereafter, “the total effective cross-sectional area of annulus 103”)may be sized so as to approximate the cross-sectional area of a selectedhollow needle gauge. For example, the total effective cross-sectionalarea of annulus 103 may be defined by:

$\begin{matrix}{{A = {{R^{2}{\tan^{- 1}\left\lbrack \sqrt{\left( \frac{R^{2}}{r} \right) - 1} \right\rbrack}} - {r\sqrt{R^{2} - r^{2}}}}},} & (1)\end{matrix}$

where, with reference to FIG. 9A, R is the radius of the circle (i.e.,an interior surface of cylindrical flexible catheter 90) and r is aperpendicular distance from the center of the circle to the outercircumference of the circle. In contrast, the area of a hollow,cylindrical needle may be defined by:

$\begin{matrix}{{A = {\pi \left( \frac{I\; D}{2} \right)}^{2}},} & (2)\end{matrix}$

where ID is the diameter of the lumen of the needle.

Accordingly, in light of equations (1) and (2), longitudinally extendingindentations 27 may be sized such that the total effectivecross-sectional area of annulus 103 (represented by reference numeral Acin FIGS. 9B and 9C) may approximate the cross-sectional area of aselected hollow needle gauge. For example, as illustrated in FIG. 9B,the approximate cross-sectional area of a 22 gauge needle may beapproximated by forming three chord-shaped longitudinally extendingdepressions 27 to a depth of 0.0047 inches within a cylindrical slenderpointed element 22 having a diameter of 0.028 inches. Similarly, asillustrated in FIG. 9C, the approximate cross-sectional area of a 25gauge needle may be approximated by forming three chord-shapedlongitudinally extending depressions 27 to a depth of 0.0024 incheswithin a cylindrical slender pointed element 22 having a diameter of0.028 inches.

FIGS. 10A-10E are perspective views of various exemplary embodiments ofa flexible catheter 90. As illustrated in these figures and as detailedabove, one or more apertures 92 may be defined within flexible catheter90 proximate a second opening 93. More particularly, as illustrated inFIGS. 10A-10D, one or more of apertures 92 may be generally circular,oval, or elongated in shape and may be formed within or proximate totapered transition region 95. In addition, as illustrated in FIG. 10E,flexible catheter 90 may comprise a permeable region 97 definedproximate second opening 93. In at least one embodiment, permeableregion 97 is configured to allow fluids, such as blood, to passtherethrough.

As illustrated in FIGS. 11A-11H, slender pointed element 22 may beformed in a variety of shapes and configurations. For example, slenderpointed element 22 may be formed to have a substantially triangularcross-section (as illustrated in FIG. 11B), a substantially cross-shapedcross-section (as illustrated in FIG. 11D), a substantially star-shapedcross-section (as illustrated in FIG. 11F), and/or a substantiallycircular cross-section (as illustrated in FIG. 11H). The total effectivecross-sectional area of an annulus 103 defined by the interior surfaceof a flexible catheter 90 and the exterior surface of slender pointedelement 22 positioned within the flexible catheter may be varied byvarying the cross-sectional shape and size of slender pointed element22. In other embodiments, flexible catheter 90 may be configured toallow fluid communication between an exterior surface of slender pointedelement 22 and an interior surface of flexible catheter 90. In aparticular embodiment, there is no need to remove material from slenderpointed element 22 to provide fluid communication between the interiorsurface of flexible catheter 90 and the exterior surface of slenderpointed element 22.

FIGS. 12A and 12B are cross-sectional and perspective views,respectively, of an additional embodiment of a slender pointed element22 positioned within an exemplary flexible catheter 90. As illustratedin these figures, slender pointed element 22 may comprise a solidpointed end 25 and a lumen 105 defined within at least a portion of thebody of slender pointed element 22. In addition, a plurality ofapertures 108 defined within slender pointed element 22 may providefluid communication between one or more apertures 92 defined throughflexible catheter 90 and lumen 105 of slender pointed element 22. In atleast one embodiment, fluid may flow through at least one aperture 92defined through flexible catheter 90 and through a correspondingaperture 108 defined in slender pointed element 22. In such aconfiguration, annulus 103 may be omitted, if desired.

In certain embodiments, apertures 108 may be defined such that, wheninsertion assembly 20 is coupled to hub 40, apertures 108 are positionedproximate manifold element 61 of hub 40. In this exemplaryconfiguration, fluid may flow through apertures 92 and 108, into lumen105, through an aperture 33 defined in slender pointed element 22 and acorresponding aperture 37 defined in flexible catheter 90, throughopening 53 of manifold element 61, out of opening 49 of manifold element49, and into an extension tube, such as extension tube 70. Such aconfiguration may be desirable for providing a simple and robust fluidcommunication path between extension tubing 70 and an internal fluidchamber of an implanted device, such as chamber 324 of exemplary accessport 320.

FIG. 13 is a partial cross-sectional side view of an additionalembodiment of a flexible catheter 90. As seen in this figure, flexiblecatheter 90 may further comprise a reinforcing member 102. In at leastone embodiment, reinforcing member 102 may be at least partiallyimbedded within flexible catheter 90. Reinforcing member 102 may alsocomprise a coiled, stainless steel wire (formed of, for example, AISI304 stainless steel) and may have a generally circular, generally oval,rectangular, triangular, or otherwise shaped cross-section. In certainembodiments, reinforcing member 102 may be coiled within flexiblecatheter 90 to extend in a substantially spiral or helical fashion.Reinforcing member 102 may also be structured for, among otherreinforcing functions, resisting external radial forces applied toflexible catheter 90, thereby helping to prevent the inward collapse offlexible catheter 90. In addition, reinforcing member 102 may amelioratekinking of flexible catheter 90. Reinforcing member 102 may also besized and positioned within flexible catheter 90 so as to avoidintersecting with apertures 92 defined in flexible catheter. In thisexemplary embodiment, apertures 92 may be formed through flexiblecatheter 90 by drilling or punching out portions of flexible catheter90, or as otherwise known in the art. Optionally, apertures 92 may bedefined through coiled reinforcing member 102 if necessary or desirable.

As will be appreciated by those of ordinary skill in the art, a numberof additional insertion assembly embodiments and hub embodiments fallwithin the spirit and scope of the instant disclosure. For example, asillustrated in the cross-sectional side view of FIG. 14A, hub 40 may beconfigured to have a substantially pear-shaped cross-section. In thisexemplary embodiment, hub 40 may generally comprise a hub body 50, arecess 42 configured to receive a safety clip, and a sleeve 120positioned about a septum 48. As shown in FIG. 14A, a retaining lip 43may be provided within recess 42 for retaining a safety clip, such assafety clip 30, therein. An anchor element 126 may also be positionedwithin and securely affixed to hub body 50. In certain embodiments,flexible catheter 90 may be affixed to anchor element 126 to effectivelysecure flexible catheter 90 within hub body 50.

In the exemplary embodiment illustrated in FIG. 14A, extension tube 70may be affixed to and positioned at least partially within hub body 50.A channel 122 may be defined within hub body 50 and structured to extendbetween the lumen of extension tube 70 and the lumen of flexiblecatheter 90 to provide a fluid communication path between extension tube70 and flexible catheter 90. Exemplary sleeve 120 may also be positionedabout septum 48 and securely affixed to hub body 50. In at least oneembodiment, sleeve 120 compresses septum 48 to help seal the variousperforations formed in septum 48 by slender pointed element 22.

FIG. 14B is a simplified cross-sectional side view of an exemplaryinsertion assembly 20 positioned within the exemplary hub 40 illustratedin FIG. 14A. As seen in this figure, insertion assembly 20 generallycomprises a slender pointed element 22 and a base member 28 configuredin accordance with one or more of the exemplary embodiments describedand/or illustrated herein. In certain embodiments, insertion assembly 20may be coupled to hub 40 via a coupling structure 26, a coupling recess44, and a retaining lip 43.

FIG. 15 is a simplified cross-sectional side view of an additionalembodiment of an infusion system 10 comprising an insertion assembly 20,a hub 40, a flexible catheter 90, and an extension tube 70. As withprevious embodiments, hub 40 may comprise a recess 42, a sleeve 120, anda septum 48. In certain embodiments, at least a portion of bothextension tube 70 and flexible catheter 90 may extend within hub body50. In addition, as illustrated in FIG. 15, at least a portion offlexible catheter 90 may extend within extension tube 70. In otherwords, extension tube 70 may be configured to receive and surround atleast a portion of flexible catheter 90. Accordingly, when insertionassembly 20 is fully inserted within and coupled to hub 40, slenderpointed element 22 may penetrate and pass through flexible catheter 90,extension tube 70, or both, as illustrated in FIG. 15. As with previousembodiments, sleeve 120 may compress septum 48 to aid in sealing septum48 upon removal of slender pointed element 22 from flexible catheter 90and/or extension tube 70. In an optional embodiment, a single tubularelement may extend through hub 40 and function as both flexible catheter90 and extension tube 70.

As will be appreciated by those of ordinary skill in the art, hub 40 maybe formed in any number of shapes and sizes. For example, hub 40 may besubstantially cylindrical in shape (as illustrated in FIG. 16),substantially dome-shaped (as illustrated in FIGS. 19A-19C),substantially wing-shaped (as illustrated in FIGS. 20A-20B and 21A-21E),substantially rectangular or square-shaped (as illustrated in FIGS.22A-22B and 25A-25B), substantially oblong or oval-shaped (asillustrated in FIGS. 26A-26C, 27A-27B, and 33A-33C), or formed in anyother number of suitable shapes and sizes. As will be appreciated bythose of skill in the art, the various possible shapes andconfigurations of hub 40 and insertion assembly 20 may provide variousadvantages, such as ease of handling by a user and/or compatibility withadditional structures.

FIGS. 17A and 17B are perspective views of an additional embodiment ofan infusion system. As illustrated in these figures, this exemplaryinfusion system may comprise an insertion assembly 20, a hub 40, aflexible catheter 90, an extension tube 70, a clamp 60, and a tubeconnector 80. In at least one embodiment, the exemplary infusion systemillustrated in these figures further comprises a pad member 150comprising a receiving enclosure 152 configured to receive and at leastpartially enclose hub 40. More particularly, receiving enclosure 152 maycomprise a pair of opposing retaining walls 155 sized and configured toreceive and at least partially enclose a hub, such as hub 40 in FIG.17B. Receiving enclosure 152 may also comprise a rounded channel 156structured and sized to receive at least a portion of flexible catheter90. In certain embodiments, rounded channel 156 may aid in amelioratingkinking of extension tube 70 or flexible catheter 90 by preventing sharpbends of flexible catheter 90. Pad member 150 may also comprise anaccess notch 158 for positioning pad member 150 about flexible catheter90.

In at least one embodiment, flexible catheter 90 may have a length thatexceeds an anticipated insertion length such that, when flexiblecatheter 90 is fully inserted into a device (such as exemplary accessport 320) implanted within a patient, a bendable portion 147 of flexiblecatheter 90 extends from a skin surface of the patient. Morespecifically, the length of flexible catheter 90 may be selected suchthat a portion 147 of the flexible catheter 90 extending outwardly fromthe skin surface of a patient (such as skin surface 310 illustrated inFIG. 1) may be bent or curved. This exemplary configuration may providean infusion system that facilitates favorable placement of a hub. Forexample, after insertion into a device implanted within a patient andupon removal of insertion assembly 20, flexible catheter 90 may be bentso that hub 40 may lie against the surface of the skin or may beotherwise positioned as desired. In the exemplary embodiment illustratedin FIGS. 17A-17B, flexible catheter 90 may be bent to allow hub 40 to bepositioned within receiving enclosure 152. Pad 150 may then placed onand/or affixed or taped to the skin surface of a patient. The exemplaryinfusion system illustrated in FIG. 17B thus represents a relatively lowprofile apparatus for accessing an implanted device.

As will be appreciated by those of skill in the art, pad member 150 maycomprise a receiving enclosure that is configured to accept and retain ahub (of any geometry), an extension tube, a flexible catheter, orcombinations thereof, without limitation. In addition, as illustrated inFIGS. 18A and 18B, a sleeve member 160 may surround at least a portionof flexible catheter 90. In particular, as illustrated in FIGS. 18A and18B, sleeve member 160 may be configured to surround the portion offlexible catheter 90 that extends between hub 40 and pad member 150. Incertain embodiments, sleeve member 160 may be folded or creased (e.g.,with accordion-type folds) to permit the vertical movement of hub 40relative to pad member 150. As will be appreciated by those of skill inthe art, sleeve member 160 may protect flexible catheter 90, concealblood traveling through flexible catheter 90 (if flexible catheter 90 isat least partially transparent), or ameliorate kinking of flexiblecatheter 90.

FIGS. 19A and 19B are perspective and cross-sectional side views,respectively, of an additional embodiment of an infusion system 10comprising an insertion assembly 20, a hub 40, a flexible catheter 90,an extension tube 70, a clamp 60, and a tube connector 80. Asillustrated in these figures, hub 40 may comprise a recess 42 definedwithin a hub body 50 and a sleeve 120 surrounding a septum 48 positionedwithin recess 42. In at least one embodiment, fluid communicationbetween extension tube 70 and flexible catheter 90 is provided through achannel 166 formed within hub body 50. In certain embodiments, channel166 may be formed after flexible catheter 90 and extension tube 70 havebeen affixed or molded within hub body 50. For example, a machine tool,such as a drill bit or milling bit, may pass within extension tube 70,through a portion of hub body 50, and into flexible catheter 90 to formchannel 166 and an aperture in flexible catheter 90. In an additionalembodiment, a displacement may be positioned within extension tube 70and into a preformed aperture in flexible catheter 90, and then hub body50 may be formed or molded around the assembly.

FIG. 19C is a cross-sectional side view of an additional embodiment ofan infusion system. As illustrated in this figure, the vertical (i.e.,along the axis of slender pointed element 22) height of hub 40 may bereduced by reducing the vertical height of recess 42 and safety clip 30.As will be appreciated by those of skill in the art, the size andconfiguration of each component of each exemplary embodiment describedand/or illustrated herein may be varied, modified, or otherwiseselected, without limitation.

FIGS. 20A-20B are perspective and cross-sectional side views,respectively, of an additional embodiment of an infusion system 10comprising an insertion assembly 20, a hub 40, a flexible catheter 90,an extension tube 70, a clamp 60, and a tube connector 80. As withprevious embodiments, hub 40 may generally comprise a hub body 50, amanifold element 61, and a septum 48 compressed by hub body 50 (thuseliminating the need for a sleeve, such as sleeve 120). Hub 40 may alsocomprise a plurality of wing structures 41A and 41B configured to affixhub 40 to the skin of a patient. In addition, hub 40 may comprise acoupling recess 44 configured to receive a complimentary couplingstructure 26 provided on base member 28 of insertion assembly 20. Hub 40may also comprise a recess 42 having a retaining lip 43 for retaining atleast a portion of a safety clip, such as safety clip 30, within recess42. A channel 166 extending from extension tube 70 to an upper end offlexible catheter 90 may also be defined within hub body 50 forproviding fluid communication between extension tube 70 and flexiblecatheter 90.

FIGS. 21A-21E are perspective and cross-sectional views of variousexemplary components of an additional embodiment of an infusion system10. As seen in FIG. 21A, exemplary infusion system 10 may comprise aninsertion assembly 20, a hub 40, a flexible catheter 90, an extensiontube 70, a clamp 60, and a tube connector 80. In at least oneembodiment, infusion system 10 may also comprise a winged component 170positioned between insertion assembly 20 and hub 40. As shown in FIG.21C, winged component 170 may comprise a coupling recess 172 definedwithin a body 174. A plurality of wing structures 41A and 41B may extendfrom body 174, as shown in FIG. 21C. In certain embodiments, couplingrecess 172 may be configured to receive a complimentary couplingstructure 26 provided on a base member 28 of insertion assembly 20.Similarly, as illustrated in FIG. 21D, hub 40 may comprise an opening178 for accepting the body 174 of winged component 170. Hub 40 may alsocomprise a recess 42 and wing-shaped depressions 177 for accepting wingstructures 41A and 41B of winged component 170. In general, wingedcomponent 170 may be affixed to hub 40 by any means known to those ofskill in the art, including, for example, by adhering body 174 withinopening 178 of hub 40 using an adhesive.

FIGS. 22A-22B are cross-sectional side views of an exemplary safety cliphousing 240. Safety clip housing 240 generally represents any structureconfigured to at least partially enclose a safety clip of any shape orsize; including, for example, the various safety clip embodimentsdescribed and/or illustrated herein. In the exemplary embodimentillustrated in FIGS. 22A-22B, safety clip housing 240 may be configuredto house a substantially rectangular safety clip 30. As illustrated inthese figures, safety clip housing 240 may comprise a hole 242 sized forreceiving a slender pointed element, such as slender pointed element 22.Safety clip housing 240 may also comprise a base member 244 sized to fitwithin a recess 42 defined in hub 40, as illustrated in FIG. 22B.

FIGS. 23A and 23B are perspective views of an additional embodiment of asafety clip 30. Safety clip 30 generally represents any self-actuatingdevice for capturing a pointed end of a slender pointed element, such aspointed end 25 of slender pointed element 22 illustrated in FIG. 3A. Inthe exemplary embodiment illustrated in FIG. 23A, safety clip 30 maycomprise a plurality of legs 32A and 32B having curved end regions 35Aand 35B, respectively, and a hole 34 sized for receiving a slenderpointed element, such as slender pointed element 22. In at least oneembodiment, safety clip 30 may be sized to fit within a recess definedin an insertion assembly, such as recess 24 defined in insertionassembly 20 illustrated in FIG. 3B. Safety clip 30 may also be sized tofit within a recess defined in a hub of an infusion system, such asrecess 42 of hub 40, or sized to fit within a safety clip housing, suchas safety clip housing 240.

In at least one embodiment, safety clip 30 is attached to slenderpointed element 22 by passing the pointed end 25 of slender pointedelement 22 through hole 34 of safety clip 30, past legs 32A and 32B, andpast curved end regions 35A and 35B. Once pointed end 25 of slenderpointed element 22 has passed curved end regions 35A and 35B, legs 32Aand 32B may clamp around slender pointed element 22 to removably affixthe safety clip to slender pointed element 22. As slender pointedelement 22, together with safety clip 30, is inserted into recess 42defined in hub body 50, slender pointed element 22 may continue throughsafety clip 30 and into a sealable path defined in a hub body, such ashub body 50. In addition, legs 32A and 32B of safety clip 30 may bebiased such that, upon removal of slender pointed element 22 from thesealable path defined in hub body 50, curved end regions 35A and 35B mayclose around the pointed end 25 of slender pointed element 22 to retainthe pointed end 25 within the body of safety clip 30. Such a safety clip30 may prevent inadvertent insertion of slender pointed element 22 intoanother person, such as a medical practitioner utilizing infusion system10.

FIGS. 24A-24D are perspective and cross-sectional side views of anadditional embodiment of a safety clip 30. As seen in these figures,safety clip 30 may comprise a hole 34 sized for receiving a slenderpointed element (such as slender pointed element 22), a first leg 32Acomprising an upper arm portion 35A and a lower arm portion 39A, and asecond leg 32B comprising an upper arm portion 35B and a lower armportion 39B. In at least one embodiment, safety clip 30 may be sized tofit within a recess defined in an insertion assembly, such as recess 24defined in insertion assembly 20 illustrated in FIG. 3B. Safety clip 30may also be sized to fit within a recess defined in a hub of an infusionsystem, such as recess 42 of hub 40, or sized to fit within a safetyclip housing, such as safety clip housing 240.

In at least one embodiment, upper arm portions 35A and 35B and lower armportions 39A and 39B of safety clip 30 may be configured to retain thepointed end 25 of slender pointed element 22 within the body of safetyclip 30. For example, legs 32A and 32B of safety clip 30 may be biasedsuch that, upon removal of slender pointed element 22 from hub body 50,lower arm portions 39A and 39B may close around the pointed end 25 ofslender pointed element 22 to retain the pointed end 25 within the bodyof safety clip 30. In addition, upper arm portions 35A and 35B may beconfigured to prevent a protrusion 45 provided on slender pointedelement 22 from passing upwards through hole 34. Similarly, lower armportions 39A and 39B may be configured to allow the protrusion 45provided on slender element 22 to enter the body of safety clip 30, butto prevent the protrusion 45 from passing downwards past lower armportions 39A and 39B. Such a safety clip 30 may prevent inadvertentinsertion of slender pointed element 22 into another person, such as amedical practitioner utilizing infusion system 10.

As detailed above, one or more of the exemplary safety clip embodimentsdescribed and/or illustrated herein may be sized so as to fit within asafety clip housing, such as safety clip housing 240 illustrated inFIGS. 22A-22B. As will be appreciated by those of skill in the art, sucha safety clip housing may be attached or affixed to a slender pointedelement, to a hub, or both, in any number of ways. For example, asillustrated in the schematic cross-sectional side view of FIG. 25A, asafety clip housing 240 may be configured to be removably attachable toa portion of a hub 40. More specifically, safety clip housing 240 maycomprise a base member 244 configured to snap-fit over a plurality ofcomplimentary protrusions 250 provided on hub 40. Optionally, asillustrated in FIG. 25B, base member 244 of safety clip housing 240 maybe positioned and permanently adhered within a recess 42 provided in hub40.

FIGS. 26A-26C are perspective views of an additional embodiment of aninfusion system comprising an insertion assembly 20, a hub 40, aflexible catheter 90, an extension tube 70, and a tube connector 80. Inat least one embodiment, a removable member 180 in fluid communicationwith extension tube 70 may be configured to be removably attachable to ahub body 50 of hub 40. For example, hub body 50 may comprise one or morecoupling recesses 192 configured to receive complimentary couplingstructures 182 provided on removable member 180. Accordingly, removablemember 180 may be coupled to hub body 50 by positioning couplingstructures 182 within complimentary coupling recesses 192. In certainembodiments, removable member 180 may also comprise a pointed tubularelement 184 in fluid communication with extension tube 70. Generallyspeaking, pointed tubular element 184 may be configured to penetrate apenetrable septum 194 provided within hub body 50. In at least oneembodiment, penetrable septum 194 seals a tubing portion 196 in fluidconnection with flexible catheter 90. Thus, a fluid communication pathbetween flexible catheter 90 and extension tube 70 may be established byinserting tubular element 184 through septum 194 and into tubing portion196 housed in hub body 50.

Persons of ordinary skill in the art will appreciate that extension tube70 may be removably attached to hub 40 and/or flexible catheter 90 inany number of ways. For example, as illustrated in FIG. 27A, extensiontube 70 may be removably attached to the hub body 50 of hub 40 bypositioning a male tube connector 202 provided on hub body 50 within acomplimentary female tube connector 204 attached to extension tube 70.Generally speaking, complimentary tube connectors 202 and 204 representany form of tubing connection or mechanism known to those of skill inthe art; including, for example, a so-called Luer-type fitting orconnector. In an additional embodiment, male tube connector 202 may bepositioned within a recess 206 defined within hub body 50 of hub 40, asillustrated in FIG. 27B.

FIGS. 28A and 28B are perspective and cross-sectional views,respectively, of an infusion system according to an additionalembodiment. As seen in these figures, this exemplary infusion system maycomprise an insertion assembly 20, a base member 40, a flexible catheter90, and an extension tube 70. In at least one embodiment, a cap element46 may be inserted within a recess 42 defined in hub body 50. Capelement 46 generally represents any structure or device capable ofsealing any aperture or recess defined within any of the components ofthe exemplary embodiments described and/or illustrated herein. Incertain embodiments, cap element 46 may be positioned above septum 48and configured to seal recess 42 from the environment, therebypreventing bacteria from entering and forming within recess 42. In anadditional embodiment, a cap element 46 is disposed within each exposedrecess and/or aperture defined in each component of exemplary infusionapparatus 10. Cap element 46 may be formed of any suitable materialcapable of sealing an aperture or recess; including, for example,medical-grade polymers (such as silicone) and monomers (such as EthylenePropylene Diene Monomer (“EPDM”), or other suitable materials.

FIG. 29 illustrates an exemplary slender pointed element 22 comprising apointed end 25. As illustrated in this figure, the pointed end 25 ofslender pointed element 22 may be scored or otherwise weakened alongline 23. Accordingly, upon completion of an infusion operation, thepointed end 25 of slender pointed element 22 may break off along line 23upon removal of slender pointed element 22 from hub body 50, leaving thebroken pointed end 25 of slender pointed element 22 within septum 48.

In at least one embodiment of infusion system 10, at least a portion ofslender pointed element 22 may be retractable into a recess defined ininsertion assembly 20. For example, as illustrated in FIGS. 30A-30B, alever 200 coupled to slender pointed element 22 may be provided in arecess 29 defined in base member 28 of insertion assembly 20. In certainembodiments, lever 200 may be manipulated from a first positionillustrated in FIG. 30A to a second position illustrated in FIG. 30B toretract at least a portion of slender pointed element 22 within basemember 28. After pointed end 25 of slender pointed element 22 has beenretracted past a second opening 93 of flexible catheter 90, a blood drawmay be attempted to ensure the proper placement of flexible catheter 90within the implanted device.

Similarly, as illustrated in FIGS. 31A-31D, a slender pointed element(such as slender pointed element 22 in FIG. 3A) may be retracted intobase member 28 by depressing opposing buttons 210 and 214 provided onbase member 28. In this exemplary embodiment, buttons 210 and 214 maycomprise cantilevered end portions 212 and 216, respectively, that areconfigured to manipulate a complimentary cantilevered end portion 220 ofslender pointed element 22 generally upwards within a recess defined inbase member 28. In an additional embodiment, as illustrated in FIGS.32A-32D, slender pointed element 22 may be retracted into base member 28by manipulating wing structures 41A and 41B from a first position,illustrated in FIGS. 32A and 32C, into a second position, illustrated inFIGS. 32B and 32D. More particularly, wing structures 41A and 41B maycomprise cantilevered end portions 230A and 230B, respectively, that areconfigured to manipulate slender pointed element 22 generally upwardswithin a recess defined in base member 28.

FIGS. 33A-33C are perspective views of an additional embodiment of aninfusion apparatus 10. As seen in these figures, infusion apparatus 10may comprise an insertion assembly 20, a hub 40, a flexible catheter 90,an extension tube 70, a clamp 60, and a tube connector 80. Insertionassembly 20 may comprise a biasing member 232 positioned around aslender pointed element 22 and positioned proximate a safety clip 30. Inat least one embodiment, biasing member 232 may bias safety clip 30 awayfrom insertion assembly 20 such that, upon removal of insertion assembly20 from hub 40, safety clip 30 may positioned around a pointed end 25 ofslender pointed element 22 by biasing member 232.

As best seen in FIG. 33C, insertion assembly 20 may also comprise aplurality of coupling arms 234 that define a recess 236 that isconfigured to receive at least a portion of hub 40. For example, hub 40may be sized and shaped so as to fit within the recess 236 definedwithin insertion assembly 20 by coupling arms 234. In at least oneembodiment, the exemplary configuration of infusion system 10 in FIGS.33A-33C may provide various advantages, such as ease of handling by auser and/or compatibility with additional structures.

FIGS. 34A-34C are perspective views of an exemplary hub 40 for aninfusion system according to an additional embodiment. As seen in thesefigures, exemplary hub 40 may comprise a plurality of wing structures41A and 41B. In at least one embodiment, wing structures 41A and 41B areconfigured to affix exemplary hub 40 to the skin of a patient. Forexample, wing structures 41A and 41B may be taped, adhesively affixed,or otherwise attached to the surface of a patient's skin, such as skinsurface 310 in FIG. 1. In additional embodiment, a sheet of material,such as TEGADERM®, may be used to affix hub 40 to the surface of apatient's skin.

As seen in FIG. 34A, hub 40 may comprise a recess 260 and a receivingenclosure 264. In at least one embodiment, recess 260 is sized andconfigured to receive at least a portion of a flexible catheter, such asflexible catheter 90 in FIGS. 34B-34C. Similarly, receiving enclosure264 may be sized and configured to retain at least a portion of aflexible catheter, such as flexible catheter 90 in FIGS. 34B-34C. Incertain embodiments, wing structures 41A and 41B of hub 40 may beconfigured to fold inwardly along a folding line 266. As best seen inFIGS. 34B and 34C, after positioning at least a portion flexiblecatheter 90 within recess 260 and receiving enclosure 264, wingstructures 41A and 41B may be folded inwardly upward. In one embodiment,wing structures 41A and 41B may be affixed to a patient's skin when in adownward, extended position, illustrated in FIG. 34B. In addition,flexible catheter 90 and/or a slender pointed element, such as slenderpointed element 22 in FIG. 3A, may be removed from hub 40 when wingstructures 41A and 41B are in an upward, folded position, illustrated inFIG. 34C.

As detailed above, one or more of the exemplary embodiments describedand/or illustrated herein may be employed in accessing a device, such asexemplary access port 320, implanted within a patient. In at least oneembodiment, a method of accessing an implanted device using a infusionsystem may comprise: 1) positioning at least a portion of slenderpointed element 22 within flexible catheter 90; 2) penetrating a septumof an implanted device, such as septum 326 of access port 320, using theslender pointed element 22 positioned within the flexible catheter 90;and 3) positioning at least a portion of flexible catheter 90 within theimplanted device. For example, a clinician may grasp base member 28 ofinsertion assembly 20 and may guide the pointed end 25 of slenderpointed element 22 into recess 42 of hub 40, through septum 48, and intoflexible catheter 90. The clinician may then guide the pointed end 25 ofslender pointed element 22 (positioned within flexible catheter 90)through the skin surface 310 and subcutaneous zone 312 of a patient andinto a port septum 326. The clinician may then confirm that flexiblecatheter 90 is positioned within chamber 324 of access port 320 bydrawing blood through extension tube 70 using a syringe attached to tubeconnector 80. Thus, blood may be drawn through apertures 92 of flexiblecatheter 90 and through at least one cavity formed between an innersurface of flexible catheter 90 and an outer surface of slender pointedelement 22. Blood may then travel through hub 40 (i.e., manifold element61) and through extension tube 70 to confirm that slender pointedelement 22 and flexible catheter 90 of infusion system 10 are properlyplaced within port chamber 324.

Subsequent to confirmation of proper placement of slender pointedelement 22 and flexible catheter 90, base member 28 of insertionassembly 20 may be grasped and slender pointed element 22 may be removedfrom hub 40, while flexible catheter 90 may remain positioned withinchamber 324 of access port 320. Septum 48 may seal any hole or aperturecreated by the removal of slender pointed element 22. Upon removal ofslender pointed element 22, flexible catheter 90 may be positioned ororiented in any number of ways; including for example, by positioningflexible catheter 90 substantially perpendicularly to skin surface 310.Safety clip 30 may remain attached to hub 40 (i.e., within recess 42)until the pointed tip 25 of slender pointed element 22 becomes encasedby safety clip 30 (via movement of legs 32A and 32B), after which timesafety clip 30 may be removed from recess 42 of hub 40. Hub 40,extension tube 70, tube connector 80, or combinations thereof may thenbe taped to skin surface 310 of the patient. Optionally, wing structures41A and 41B may be adhesively affixed to skin surface 310.

Accordingly, each of the exemplary infusion system embodiments describedand/or illustrated herein may provide vascular access (via an implanteddevice) for any number of procedures; including, for example, infusion,blood aspiration, hemodialysis, hemofiltration, peritoneal dialysis, orother procedures as known in the art. Advantageously, the use of sharpimplements may be reduced or eliminated, thereby reducing the danger ofinadvertent sticks or punctures.

The preceding description has been provided to enable others skilled inthe art to best utilize various aspects of the exemplary embodimentsdescribed herein. This exemplary description is not intended to beexhaustive or to be limited to any precise form disclosed. Manymodifications and variations are possible without departing from thespirit and scope of the instant disclosure. For example, each componentin each exemplary embodiment described and/or illustrated herein may beformed in any number of suitable shapes, sizes, and configurations. Inaddition, the various infusion system embodiments described herein maybe adapted for use in connection with high pressure operations, commonlyreferred to as “power injection” processes. Accordingly, the variouscomponents of the exemplary embodiments provided herein may be adaptedto handle pressure of about 400 psi or higher.

The embodiments described and/or illustrated herein are in all respectsillustrative and not restrictive. Accordingly, reference should be madeto the appended claims and their equivalents for determining the scopeof the instant disclosure. For ease of use, the words “including” and“having,” as used in the specification and claims, are interchangeablewith and have the same meaning as the word “comprising.”

What is claimed is:
 1. A method of treating a patient, comprising:providing an insertion assembly, including: a non-coring needle; asafety device for capturing a tip of the needle, the safety deviceincluding a self-actuating member positioned in a safety housing; a hubincluding a sealable path along which the needle may move; a catheterextending from the hub in a first direction; and an extension tubeextending from the hub in a second direction different from the firstdirection; penetrating a septum of an implanted device within thepatient using the needle while the needle extends along the sealablepath and is positioned at least partially within the catheter;positioning at least a portion of the catheter within the implanteddevice; and removing the needle from the catheter while retaining atleast a portion of the catheter within the implanted device.
 2. Themethod according to claim 1, further comprising power injecting a fluidthrough the hub and the implanted device.
 3. The method according toclaim 1, wherein the catheter comprises a tapered transition region atthe distal end, and wherein positioning at least a portion of thecatheter within the implanted device includes positioning the taperedtransition region within the implanted device.
 4. The method accordingto claim 3, wherein the tapered transition region includes a firsttapered sub-region defining a first angle relative to the firstdirection and a second tapered sub-region defining a second differentangle relative to the first direction, and wherein positioning thetapered transition region within the implanted device includespositioning the first tapered sub-region and the second taperedsub-region within the implanted device.
 5. The method according to claim1, wherein removing the needle from the catheter further comprisesremoving and separating the needle from the hub.
 6. The method accordingto claim 5, wherein the safety device is removably attached to the hub,and wherein the tip of the needle is captured within the safety deviceand the safety device is removed and separated from the hub with theneedle during the step of removing and separating the needle from thehub.
 7. The method according to claim 6, wherein the needle is attachedto a base member, and wherein when penetrating the septum of theimplanted device within the patient using the needle, the safety deviceis positioned in a recess defined in the base member.
 8. The methodaccording to claim 6, wherein the self-actuating member comprises asafety clip including a portion that closes around the tip of the needleto capture the tip of the needle during the step of removing andseparating the needle from the hub.
 9. The method according to claim 1,wherein the sealable path includes a septum that seals the sealable pathwhen the needle is removed.
 10. The method according to claim 9, furthercomprising power injecting a fluid through the hub.
 11. A method ofproviding a fluid communication path to an implanted device, the methodcomprising: positioning at least a portion of a slender pointed elementwithin a flexible catheter; penetrating a septum of an implanted devicewith the slender pointed element positioned within the flexiblecatheter; positioning at least a portion of the flexible catheter withinthe implanted device; removing the slender pointed element from theflexible catheter; and retaining at least a portion of the flexiblecatheter within the implanted device.
 12. The method according to claim11, further comprising: providing a hub in fluid communication with theflexible catheter; and removably attaching an extension tube to the hubto provide fluid communication between the flexible catheter and theextension tube.
 13. The method according to claim 12, further comprisingsealing a sealable path defined in the hub upon removal of the slenderpointed element from the flexible catheter.
 14. The method according toclaim 13, further comprising power injecting a fluid through the hub andthe implanted device.
 15. The method according to claim 11, furthercomprising retracting at least a portion of the slender pointed elementinto the flexible catheter.
 16. The method according to claim 11,further comprising: providing a safety clip proximate a pointed end ofthe slender pointed element; and retaining the pointed end of theslender pointed element within the safety clip upon removal of theslender pointed element from the flexible catheter.
 17. The methodaccording to claim 11, further comprising providing a safety device forcapturing a pointed end of the slender pointed element, the safetydevice including a self-actuating member positioned in a safety housing,wherein after removing the slender pointed element from the flexiblecatheter the pointed end of the slender pointed element is capturedwithin the safety device.
 18. The method according to claim 12, furthercomprising providing a safety device for capturing a pointed end of theslender pointed element, the safety device including a self-actuatingmember positioned in a safety housing, and the safety device beingremovably attached to the hub, wherein after removing the slenderpointed element from the flexible catheter the pointed end of theslender pointed element is captured within the safety device, and thesafety device is removed with the slender pointed element from the hub.19. The method according to claim 18, wherein the slender pointedelement is attached to a base member, and wherein when penetrating theseptum of the implanted device, the safety device is positioned in arecess defined in the base member.
 20. The method according to claim 19,wherein the self-actuating member comprises a safety clip including aportion that closes around the pointed end of the slender pointedelement to capture the pointed end of the slender pointed element withinthe safety device.